EUCTR2015-001383-18-GB进行中（未招募）不适用
An open label Phase 2 clinical trial of retinal gene therapy for choroideremia using an adeno-associated viral vector (AAV2) encoding Rab-escort protein 1 (REP1) - REGENERATE (REP1 Gene Replacement Therapy) Trial: Version 1.0
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Candidate is willing and able to give informed consent for participation in the study.
- •Male aged 18 years or above.
- •Genetic or molecular confirmed diagnosis of choroideremia (REP1 protein deficiency).
- •Active disease visible clinically within the macula region.
- •Best corrected visual acuity equal to or worse than 6/6 (20/20; Decimal 1.0; LogMAR 0) but better than or equal to 6/60 (20/200; Decimal 0.1; LogMAR 1.0) in the study eye.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Any female, or a male aged below 18 years.
- •An additional cause for sight loss (e.g. amblyopia) in the eye to be treated.
- •Any other significant ocular and non-ocular disease or disorder which, in the opinion of the investigator, may put the participants at risk because of participation in the study.
- •Inability to take systemic prednisolone for a minimum of 3 weeks.
- •Unwillingness to use barrier contraception methods for a period of three months following gene therapy surgery, if relevant.
- •Participation in another research study involving an investigational product in the preceding 12 weeks.
研究者
相似试验
进行中（未招募）
1 期
A clinical trial of nebulised recombinant tissue plasminogen activator (rtPA) in patients with COVID-19 Acute Respiratory Distress Syndrome to decrease the duration of ventilatory support and mortality: A pilot study (the PACA trial)Acute respiratory distress syndrome (ARDS) caused by COVID-19EUCTR2020-001640-26-GBniversity College London36
进行中（未招募）
1 期
A phase II randomized, open label clinical trial in high risk percutaneous coronary intervention (PCI) patients receiving standard antithrombotic treatment plus either ALX-0081 or GPIIb/IIIa inhibitor (ReoPro®) over a period of 24 hoursEUCTR2009-012206-39-BEAblynx368
进行中（未招募）
不适用
A phase II randomized, open label clinical trial in high risk percutaneous coronary intervention (PCI) patients receiving standard antithrombotic treatment plus either ALX-0081 or GPIIb/IIIa inhibitor (ReoPro®) over a period of 24 hoursThrombotic events associated with percutaneous coronary intervention (PCI) in patients with unstable angina or Non ST-Segment Elevation Myocardial Infarction (NSTEMI), or stable angina with at least 2 factors indicating a high risk PCI.MedDRA version: 9.1Level: LLTClassification code 10011076Term: Coronary artery atherosclerosisMedDRA version: 9.1Level: LLTClassification code 10011078Term: Coronary artery diseaseMedDRA version: 9.1Level: LLTClassification code 10013210Term: Disorder coronary arteryMedDRA version: 9.1Level: LLTClassification code 10063933Term: Coronary stent thrombosisMedDRA version: 9.1Level: LLTClassification code 10065608Term: Percutaneous coronary interventionMedDRA version: 9.1Level: LLTClassification code 10003211Term: Arteriosclerosis coronary arteryMedDRA version: 9.1Level: LLTClassification code 10011067Term: Coronary angiogram abnormalMedDRA version: 9.1Level: LLTClassification code 10011093Term: Coronary atherosclerosisMedDRA version: 9.1Level: LLTClassification code 10011099Term: Coronary diseaseMedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndromeEUCTR2009-012206-39-DEAblynx368
进行中（未招募）
不适用
A phase II randomized, open label clinical trial in high risk percutaneous coronary intervention (PCI) patients receiving standard antithrombotic treatment plus either ALX-0081 or GPIIb/IIIa inhibitor (ReoPro®) over a period of 24 hoursEUCTR2009-012206-39-ATAblynx368
进行中（未招募）
不适用
A phase II randomized, open label clinical trial in high risk percutaneous coronary intervention (PCI) patients receiving standard antithrombotic treatment plus either ALX-0081 or GPIIb/IIIa inhibitor (ReoPro®) over a period of 24 hoursThrombotic events associated with percutaneous coronary intervention (PCI) in patients with unstable angina or Non ST-Segment Elevation Myocardial Infarction (NSTEMI), or stable angina with at least 2 factors indicating a high risk PCI.MedDRA version: 9.1Level: LLTClassification code 10011076Term: Coronary artery atherosclerosisMedDRA version: 9.1Level: LLTClassification code 10011078Term: Coronary artery diseaseMedDRA version: 9.1Level: LLTClassification code 10013210Term: Disorder coronary arteryMedDRA version: 9.1Level: LLTClassification code 10063933Term: Coronary stent thrombosisMedDRA version: 9.1Level: LLTClassification code 10065608Term: Percutaneous coronary interventionMedDRA version: 9.1Level: LLTClassification code 10003211Term: Arteriosclerosis coronary arteryMedDRA version: 9.1Level: LLTClassification code 10011067Term: Coronary angiogram abnormalMedDRA version: 9.1Level: LLTClassification code 10011093Term: Coronary atherosclerosisMedDRA version: 9.1Level: LLTClassification code 10011099Term: Coronary diseaseMedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndromeEUCTR2009-012206-39-CZAblynx368